Conservative Pulp Therapy of Primary Molars Using TheraCAL

June 10, 2022 updated by: Mariem Wassel, Ain Shams University

Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial

The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 1156
        • Faculty of dentistry, ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Four to six years old healthy children
  • Cooperative (frankle scale + and ++)
  • With at least one vital and restorable primary molar with deep caries.

Exclusion Criteria:

  • History of spontaneous pain, swelling, or sinus tract
  • Pathological mobility
  • pain on percussion
  • Furcation or periapical radiolucency
  • Internal or external pathological root resorption
  • Widening of periodontal membrane space
  • Discontinuity of lamina dura.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: indirect pulp capping
TheraCAL PT will be applied to affected dentin covering the pup.
Drug: Dual cured resin modified tricalcium silicate cement
A resin based, dual cured tricalcium silicate based cement
Other Names:
  • TheraCal PT
EXPERIMENTAL: Direct pulp Capping
TheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin.
Drug: Dual cured resin modified tricalcium silicate cement
A resin based, dual cured tricalcium silicate based cement
Other Names:
  • TheraCal PT
EXPERIMENTAL: Partial Pulpotomy
Pulp exposure will be enlarged to a depth of 1-3 mm by a sterile round diamond bur, and then TheraCAL PT will applied after hemostasis.
Drug: Dual cured resin modified tricalcium silicate cement
A resin based, dual cured tricalcium silicate based cement
Other Names:
  • TheraCal PT
EXPERIMENTAL: pulpotomy
complete removal of coronal pulp tissue will be attempted if bleeding persisted after attempting Partial pulpotomy for exposures that are not eligible for DPC. TheraCAL PT will be applied thereafter, after achieving hemostasis.
Drug: Dual cured resin modified tricalcium silicate cement
A resin based, dual cured tricalcium silicate based cement
Other Names:
  • TheraCal PT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Visual and tactile clinical examination
Time Frame: every 6 months
Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis
every 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dental Periapical Radiographic examination
Time Frame: every 6 months
Teeth will be examined for any radiographic signs of pulp necrosis
every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Mariem Wassel, Faculty of Dentistry, Ain Sham University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 25, 2019

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

October 26, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-REC R 091902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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